HPLC梯度洗脱法测定DEPBT的纯度  

Determination of Purity of DEPBT by HPLC with Gradient Elution

作　　者：李云峰 魏振兴 郭静 胡丽英 LI Yun-feng;WEI Zhen-xing;GUO Jing;HU Li-ying(Changshan Conjuchem Biopharmaceutical Research and Development（Hebei）Co.,Ltd.,Shijiazhuang 050800,China)

机构地区：[1]常山凯捷健生物药物研发(河北)有限公司,河北石家庄050800

出　　处：《食品与药品》2018年第6期404-407,共4页Food and Drug

基　　金：国家国际科技合作专项资助项目(No.2015DFB30030)

摘　　要：目的建立HPLC法测定DEPBT纯度的方法。方法采用C18色谱柱(4.6 mm×25 cm,5μm);流动相A为0.1%TFA水溶液, B为0.1%TFA乙腈溶液,梯度洗脱:0～20 min,A:70%～0%;20～25 min,A:0%～0%;25～25.1min,A:0%～70%;25.1～35 min,A:70%～70%;流速1.0 ml/min,检测波长265nm。结果 DEPBT峰与各降解杂质峰,及各降解杂质峰间分离度均≥1.0。结论本法简便、灵敏、专属性好、结果稳定,可用于DEPBT纯度的测定。Objective To establish an HPLC method for determination of the purity of DEPBT. Methods The separation was performed on a C18 column （4.6 mm×25 cm, 5 μm）. The mobile phase A was 0.1 % TFA in water, B was 0.1 % TFA in acetonitrile, a gradient elution was performed as follows： 0-20 min, A： 70 %-0 %;20-25 min, A： 0 %-0 %; 25-25.1 min, A： 0 %-70 %; 25.1-35 min, A： 70 %-70 %. The flow rate was 1.0 ml/min and the detection wavelength was 265 nm. Results The resolutions between DEPBT peak and the degradation impurity peaks, and the resolutions between the degradation impurity peaks were all greater than 1.0. Conclusion This method is simple and sensitive, with good specifcity and stable results, thus can be used for the determination of the purity of DEPBT.

关 键 词：DEPBT 梯度洗脱法 HPLC法 纯度 测定 C18色谱柱 乙腈溶液 检测波长 

分 类 号：R927.2[医药卫生—药学]